Drugs / enmetazobactam
enmetazobactam
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Exblifep | — | 2024-03-21 | europa.eu ↗ |
| Approved | US (FDA) | EXBLIFEP | — | 2024-02-22 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT03775668 | Nov → Dec 2018 | — | Allecra | Completed | No outcome recorded |
| Phase 1 | NCT03680352 | Sep 2017 → Dec 2018 | — | Allecra | Completed | No outcome recorded |
| Phase 1 | NCT03680378 | Jul 2017 → Apr 2019 | — | Allecra | Completed | No outcome recorded |
| Phase 1 | NCT03685084 | Oct 2013 → Jan 2014 | — | Allecra | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT05826990 | Sep 2023 → Sep 2025 | urinary tract infection | Allecra | Unknown | No outcome recorded |
| Phase 2 | NCT03680612 | Sep 2017 → Feb 2018 | urinary tract infection | Allecra | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03687255 | Sep 2018 → Jan 2020 | urinary tract infection | Allecra | Completed | Met primary |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | enmetazobactam | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05826990 ↗ |
| Known as | AAI101 | “Combination of cefepime 2 gram with AAI101 1 gram” NCT03680378 ↗ |
| Known as | Enmetazobactam component of exblifep | ChEMBL registry synonym — accepted as the source's own label CHEMBL4458276 ↗ |
| Known as | OCID-5090 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4458276 ↗ |
| Modality | Small molecule | — CHEMBL4458276 ↗ |
| Route | Intravenous | “cefepime 2 grams in combination with AAI101 1 gram intravenous infusion” NCT03680378 ↗ |